Neonates and Azithromycin, an Innovation in the Treatment of Children in Burkina Faso
Status:
Active, not recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Although under-5 mortality rates are declining globally, neonatal mortality remains
persistently high in many regions of sub-Saharan Africa. Mass azithromycin distribution to
children aged 1-59 months has been shown to reduce childhood mortality in Niger, Tanzania,
and Malawi. This study did not evaluate the effect of azithromycin administered during the
neonatal period. Observational evidence from high income countries has suggested that
macrolides, including erythromycin and azithromycin, may be associated with increased risk of
development of infantile hypertrophic pyloric stenosis (IHPS). However, these studies are
limited by confounding by indication, as infants only receive antibiotics when they are ill.
The investigators proposed an individually randomized trial of azithromycin versus placebo to
establish the efficacy and safety of administration of a dose of azithromycin during the
neonatal period. The long-term goal is generate evidence that can be used by neonatal and
child survival programs related to the use of azithromycin in the youngest children who have
the highest risk of mortality. The investigators hypothesize that a single dose of
azithromycin administered in the neonatal period will lead to significantly reduced risk of
mortality and that this dose will be safe.
Objectives
1. Establish the efficacy of a single dose of azithromycin administered during the neonatal
period compared to placebo in infants 8 to 27 days of life for reduction in all-cause
mortality.
2. Establish the safety of a single dose of azithromycin administered during the neonatal
period.
This study will be conducted in several regions of Burkina Faso, including peri-urban areas
of Ouagadougou and Nouna town, and rural areas that are within 4 hours' drive of a pediatric
facility with capacity for performing pyloromyotomy
Phase:
Phase 4
Details
Lead Sponsor:
University of California, San Francisco
Collaborators:
Bill and Melinda Gates Foundation Centre de Recherche en Sante de Nouna, Burkina Faso